How to Design and Implement Powder to Tablet Continuous Manufacturing Systems

How to Design and Implement Powder to Tablet Continuous Manufacturing Systems
Author: Fernando Muzzio,Sarang Oka
Publsiher: Elsevier
Total Pages: 304
Release: 2022-04-29
ISBN 10: 0128134798
ISBN 13: 9780128134795
Language: EN, FR, DE, ES & NL

How to Design and Implement Powder to Tablet Continuous Manufacturing Systems Book Review:

How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control. With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing. Discusses the development of strategy blueprints in the design of continuous processes Shows how to create process flowsheet models from individual unit operation models Includes a chapter on characterization methods for materials, the use of statistical methods to analyze material property data, and the use of material databases Covers the evolving regulatory expectations for continuous manufacturing Provides readers with ways to more effectively navigate these expectations

How to Design and Implement Powder to Tablet Continuous Manufacturing Systems

How to Design and Implement Powder to Tablet Continuous Manufacturing Systems
Author: Fernando Muzzio,Sarang Oka
Publsiher: Academic Press
Total Pages: 442
Release: 2022-04-15
ISBN 10: 0128134801
ISBN 13: 9780128134801
Language: EN, FR, DE, ES & NL

How to Design and Implement Powder to Tablet Continuous Manufacturing Systems Book Review:

How to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems provides a comprehensive overview on the considerations necessary for the design of continuous pharmaceutical manufacturing processes. The book covers both the theory and design of continuous processing of associated unit operations, along with their characterization and control. In addition, it discusses practical insights and strategies that the editor and chapter authors have learned. Chapters cover Process Analytical Technology (PAT) tools and the application of PAT data to enable distributed process control. With numerous case studies throughout, this valuable guide is ideal for those engaged in, or learning about, continuous processing in pharmaceutical manufacturing. Discusses the development of strategy blueprints in the design of continuous processes Shows how to create process flowsheet models from individual unit operation models Includes a chapter on characterization methods for materials, the use of statistical methods to analyze material property data, and the use of material databases Covers the evolving regulatory expectations for continuous manufacturing Provides readers with ways to more effectively navigate these expectations

Process Systems Engineering for Pharmaceutical Manufacturing

Process Systems Engineering for Pharmaceutical Manufacturing
Author: Ravendra Singh,Zhihong Yuan
Publsiher: Elsevier
Total Pages: 698
Release: 2018-03-16
ISBN 10: 0444639667
ISBN 13: 9780444639660
Language: EN, FR, DE, ES & NL

Process Systems Engineering for Pharmaceutical Manufacturing Book Review:

Process Systems Engineering for Pharmaceutical Manufacturing: From Product Design to Enterprise-Wide Decisions, Volume 41, covers the following process systems engineering methods and tools for the modernization of the pharmaceutical industry: computer-aided pharmaceutical product design and pharmaceutical production processes design/synthesis; modeling and simulation of the pharmaceutical processing unit operation, integrated flowsheets and applications for design, analysis, risk assessment, sensitivity analysis, optimization, design space identification and control system design; optimal operation, control and monitoring of pharmaceutical production processes; enterprise-wide optimization and supply chain management for pharmaceutical manufacturing processes. Currently, pharmaceutical companies are going through a paradigm shift, from traditional manufacturing mode to modernized mode, built on cutting edge technology and computer-aided methods and tools. Such shifts can benefit tremendously from the application of methods and tools of process systems engineering. Introduces Process System Engineering (PSE) methods and tools for discovering, developing and deploying greener, safer, cost-effective and efficient pharmaceutical production processes Includes a wide spectrum of case studies where different PSE tools and methods are used to improve various pharmaceutical production processes with distinct final products Examines the future benefits and challenges for applying PSE methods and tools to pharmaceutical manufacturing

Continuous Pharmaceutical Processing

Continuous Pharmaceutical Processing
Author: Zoltan K Nagy,Arwa El Hagrasy,Jim Litster
Publsiher: Springer Nature
Total Pages: 541
Release: 2020-06-10
ISBN 10: 3030415244
ISBN 13: 9783030415242
Language: EN, FR, DE, ES & NL

Continuous Pharmaceutical Processing Book Review:

Continuous pharmaceutical manufacturing is currently receiving much interest from industry and regulatory authorities, with the joint aim of allowing rapid access of novel therapeutics and existing medications to the public, without compromising high quality. Research groups from different academic institutions have significantly contributed to this field with an immense amount of published research addressing a variety of topics related to continuous processing. The book is structured to have individual chapters on the different continuous unit operations involved in drug substance and drug product manufacturing. A wide spectrum of topics are covered, including basic principles of continuous manufacturing, applications of continuous flow chemistry in drug synthesis, continuous crystallization, continuous drying, feeders and blenders, roll compaction and continuous wet granulation.The underlying theme for each of these chapters is to present to the reader the recent advances in modeling, experimental investigations and equipment design as they pertain to each individual unit operation. The book also includes chapters on quality by design (QbD) and process analytical technology (PAT) for continuous processing, process control strategies including new concepts of quality-by-control (QbC), real-time process management and plant optimization, business and supply chain considerations related to continuous manufacturing as well as safety guidelines related to continuous chemistry. A separate chapter is dedicated to discussing regulatory aspects of continuous manufacturing, with description of current regulatory environment quality/GMP aspects, as well as regulatory gaps and challenges. Our aim from publishing this book is to make it a valuable reference for readers interested in this topic, with a desire to gain a fundamental understanding of engineering principles and mechanistic studies utilized in understanding and developing continuous processes. In addition, our advanced readers and practitioners in this field will find that the technical content of Continuous Pharmaceutical Processing is at the forefront of recent technological advances, with coverage of future prospects and challenges for this technology.

Continuous Manufacturing of Pharmaceuticals

Continuous Manufacturing of Pharmaceuticals
Author: Peter Kleinebudde,Johannes Khinast,Jukka Rantanen
Publsiher: John Wiley & Sons
Total Pages: 627
Release: 2017-09-05
ISBN 10: 1119001323
ISBN 13: 9781119001324
Language: EN, FR, DE, ES & NL

Continuous Manufacturing of Pharmaceuticals Book Review:

A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

Continuous Manufacturing of Pharmaceuticals

Continuous Manufacturing of Pharmaceuticals
Author: Peter Kleinebudde,Johannes Khinast,Jukka Rantanen
Publsiher: John Wiley & Sons
Total Pages: 632
Release: 2017-07-14
ISBN 10: 1119001358
ISBN 13: 9781119001355
Language: EN, FR, DE, ES & NL

Continuous Manufacturing of Pharmaceuticals Book Review:

A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency. This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles. Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.

Combined Scheduling and Control

Combined Scheduling and Control
Author: John D. Hedengren,Logan Beal
Publsiher: MDPI
Total Pages: 175
Release: 2018-04-13
ISBN 10: 3038428051
ISBN 13: 9783038428053
Language: EN, FR, DE, ES & NL

Combined Scheduling and Control Book Review:

This book is a printed edition of the Special Issue "Combined Scheduling and Control" that was published in Processes

Formulation and Validation of a Population Balance Model for Powder Mixing Process

Formulation and Validation of a Population Balance Model for Powder Mixing Process
Author: Joyce John
Publsiher: Unknown
Total Pages: 62
Release: 2013
ISBN 10: 1928374650XXX
ISBN 13: OCLC:856979307
Language: EN, FR, DE, ES & NL

Formulation and Validation of a Population Balance Model for Powder Mixing Process Book Review:

Pharmaceutical processing is much more stringent with regulatory requirements for the processing and handling stages and the product quality specifications must be met at every step during the manufacturing operation. In the pharmaceutical manufacturing, the unit operation that is one among the most widely used, is the powder blending operation. The scope of this work is to characterize and document the complex powder blending process by means of a robust predictive model and use it to enhance operational efficiency and improve on the established monitoring and control strategies. The implementation of QbD (Quality by Design) strategies [1] to continuous processing stages allows for improved process control, higher cost-efficiency without compromising on the quality or efficacy of the final product. It also would alleviate the need for further scale up studies. In this work, a population balance model (PBM) has been formulated and validated to model the complex dynamics within a continuous powder mixing process, with the focus on the blending operation taking place within pharmaceutical tablet manufacturing. PBM modeling was selected to model the blending unit operation as it not only serves as a dynamic and highly effective tool, but also due to its relative computational simplicity. The model was designed to determine the critical quality attributes (such as RTD (residence time distribution), API composition and RSD (relative standard deviation) of the product by incorporating the key process parameters such as the impeller RPM, dimensions of the blender and design parameters such as the number of compartments (both axial and radial), etc. The model obtained has been subsequently validated to check the fit between the predicted values of these CQAs (Critical Quality Attributes) against experimentally obtained data during the same time intervals. The model has the potential use for process improvement by implementation in a PAT (Process Analytical Technique) system for designing improved monitoring, control and optimization techniques. [2].

Predictive Modeling of Pharmaceutical Unit Operations

Predictive Modeling of Pharmaceutical Unit Operations
Author: Preetanshu Pandey,Rahul Bharadwaj
Publsiher: Woodhead Publishing
Total Pages: 464
Release: 2016-09-26
ISBN 10: 0081001800
ISBN 13: 9780081001806
Language: EN, FR, DE, ES & NL

Predictive Modeling of Pharmaceutical Unit Operations Book Review:

The use of modeling and simulation tools is rapidly gaining prominence in the pharmaceutical industry covering a wide range of applications. This book focuses on modeling and simulation tools as they pertain to drug product manufacturing processes, although similar principles and tools may apply to many other areas. Modeling tools can improve fundamental process understanding and provide valuable insights into the manufacturing processes, which can result in significant process improvements and cost savings. With FDA mandating the use of Quality by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included. Explains the commonly used modeling and simulation tools Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing Practical examples of the application of modeling tools through case studies Discussion of modeling techniques used for a risk-based approach to regulatory filings Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
Author: Sarwar Beg,Md Saquib Hasnain
Publsiher: Academic Press
Total Pages: 448
Release: 2019-03-27
ISBN 10: 0128163720
ISBN 13: 9780128163726
Language: EN, FR, DE, ES & NL

Pharmaceutical Quality by Design Book Review:

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Hot Melt Extrusion

Hot Melt Extrusion
Author: Dennis Douroumis
Publsiher: John Wiley & Sons
Total Pages: 400
Release: 2012-04-24
ISBN 10: 1118307879
ISBN 13: 9781118307878
Language: EN, FR, DE, ES & NL

Hot Melt Extrusion Book Review:

Hot-melt extrusion (HME) - melting a substance and forcing it through an orifice under controlled conditions to form a new material - is an emerging processing technology in the pharmaceutical industry for the preparation of various dosage forms and drug delivery systems, for example granules and sustained release tablets. Hot-Melt Extrusion: Pharmaceutical Applications covers the main instrumentation, operation principles and theoretical background of HME. It then focuses on HME drug delivery systems, dosage forms and clinical studies (including pharmacokinetics and bioavailability) of HME products. Finally, the book includes some recent and novel HME applications, scale -up considerations and regulatory issues. Topics covered include: principles and die design of single screw extrusion twin screw extrusion techniques and practices in the laboratory and on production scale HME developments for the pharmaceutical industry solubility parameters for prediction of drug/polymer miscibility in HME formulations the influence of plasticizers in HME applications of polymethacrylate polymers in HME HME of ethylcellulose, hypromellose, and polyethylene oxide bioadhesion properties of polymeric films produced by HME taste masking using HME clinical studies, bioavailability and pharmacokinetics of HME products injection moulding and HME processing for pharmaceutical materials laminar dispersive & distributive mixing with dissolution and applications to HME technological considerations related to scale-up of HME processes devices and implant systems by HME an FDA perspective on HME product and process understanding improved process understanding and control of an HME process with near-infrared spectroscopy Hot-Melt Extrusion: Pharmaceutical Applications is an essential multidisciplinary guide to the emerging pharmaceutical uses of this processing technology for researchers in academia and industry working in drug formulation and delivery, pharmaceutical engineering and processing, and polymers and materials science. This is the first book from our brand new series Advances in Pharmaceutical Technology. Find out more about the series here.

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
Author: Gintaras V. Reklaitis,Christine Seymour,Salvador García-Munoz
Publsiher: John Wiley & Sons
Total Pages: 416
Release: 2017-09-01
ISBN 10: 1119356172
ISBN 13: 9781119356172
Language: EN, FR, DE, ES & NL

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture Book Review:

Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.

Chemical Engineering Design

Chemical Engineering Design
Author: Gavin Towler,Ray Sinnott
Publsiher: Elsevier
Total Pages: 1320
Release: 2012-01-25
ISBN 10: 0080966608
ISBN 13: 9780080966601
Language: EN, FR, DE, ES & NL

Chemical Engineering Design Book Review:

Chemical Engineering Design, Second Edition, deals with the application of chemical engineering principles to the design of chemical processes and equipment. Revised throughout, this edition has been specifically developed for the U.S. market. It provides the latest US codes and standards, including API, ASME and ISA design codes and ANSI standards. It contains new discussions of conceptual plant design, flowsheet development, and revamp design; extended coverage of capital cost estimation, process costing, and economics; and new chapters on equipment selection, reactor design, and solids handling processes. A rigorous pedagogy assists learning, with detailed worked examples, end of chapter exercises, plus supporting data, and Excel spreadsheet calculations, plus over 150 Patent References for downloading from the companion website. Extensive instructor resources, including 1170 lecture slides and a fully worked solutions manual are available to adopting instructors. This text is designed for chemical and biochemical engineering students (senior undergraduate year, plus appropriate for capstone design courses where taken, plus graduates) and lecturers/tutors, and professionals in industry (chemical process, biochemical, pharmaceutical, petrochemical sectors). New to this edition: Revised organization into Part I: Process Design, and Part II: Plant Design. The broad themes of Part I are flowsheet development, economic analysis, safety and environmental impact and optimization. Part II contains chapters on equipment design and selection that can be used as supplements to a lecture course or as essential references for students or practicing engineers working on design projects. New discussion of conceptual plant design, flowsheet development and revamp design Significantly increased coverage of capital cost estimation, process costing and economics New chapters on equipment selection, reactor design and solids handling processes New sections on fermentation, adsorption, membrane separations, ion exchange and chromatography Increased coverage of batch processing, food, pharmaceutical and biological processes All equipment chapters in Part II revised and updated with current information Updated throughout for latest US codes and standards, including API, ASME and ISA design codes and ANSI standards Additional worked examples and homework problems The most complete and up to date coverage of equipment selection 108 realistic commercial design projects from diverse industries A rigorous pedagogy assists learning, with detailed worked examples, end of chapter exercises, plus supporting data and Excel spreadsheet calculations plus over 150 Patent References, for downloading from the companion website Extensive instructor resources: 1170 lecture slides plus fully worked solutions manual available to adopting instructors

New Trends in Pharmacokinetics

New Trends in Pharmacokinetics
Author: Aldo Rescigno,Ajit K. Thakur
Publsiher: Springer Science & Business Media
Total Pages: 456
Release: 2012-12-06
ISBN 10: 1468480537
ISBN 13: 9781468480535
Language: EN, FR, DE, ES & NL

New Trends in Pharmacokinetics Book Review:

The last decade or so has witnessed tremendous progress in methodology in the field of drug development in general and pharmacokinetics in particular. Clinical pharmacokinetics is using new tools for probing into the "black box" once being ac cessible only partly through experimental techniques and, mostly through mathemati cal and computer means. Development of computerized scanning, positron emission tomography (PET), stereoselectivity and other techniques are now enabling investi gators to have better pictures of the systems they are studying. Mathematical models through computer simulation and statistical estimation, mostly due to easy access be cause of inexpensive yet powerful personal computers, are enabling us to investigate ultrastructures and their functional connectivity in more detail. As a consequence, new hypotheses are being formed and tested in various related fields. In clinical pharmacokinetics, mostly due to mathematical modeling, more accurate interspecies scaling of pharmacokinetic parameters and dosimetry can be done now-a-days. The concept of "a human is a bigger rat" does not necessarily fly as a consequence. Pharmacokinetic concepts are becoming powerful tools in meaningful carcinogenic and toxic risk extrapolation of different chemicals in humans. New dose delivery designs are being formulated using pharmacokinetic techniques for different pharmaceutical compounds. Investigations continue in the academia, research institutions, pharmaceutical, biotechnological, and agricultural industries in developmental and physiological aspects of different chemicals for the benefit of mankind. The idea of a school on "New Trends in Pharmacokinetics", from which the present pUblication was made possible, took shape over almost a year.

Mass Production Processes

Mass Production Processes
Author: Anil Akdogan,Ali Serdar Vanli
Publsiher: BoD – Books on Demand
Total Pages: 212
Release: 2020-03-11
ISBN 10: 1838802150
ISBN 13: 9781838802158
Language: EN, FR, DE, ES & NL

Mass Production Processes Book Review:

It is always hard to set manufacturing systems to produce large quantities of standardized parts. Controlling these mass production lines needs deep knowledge, hard experience, and the required related tools as well. The use of modern methods and techniques to produce a large quantity of products within productive manufacturing processes provides improvements in manufacturing costs and product quality. In order to serve these purposes, this book aims to reflect on the advanced manufacturing systems of different alloys in production with related components and automation technologies. Additionally, it focuses on mass production processes designed according to Industry 4.0 considering different kinds of quality and improvement works in mass production systems for high productive and sustainable manufacturing. This book may be interesting to researchers, industrial employees, or any other partners who work for better quality manufacturing at any stage of the mass production processes.

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook
Author: Shayne Cox Gad
Publsiher: John Wiley & Sons
Total Pages: 1384
Release: 2008-03-21
ISBN 10: 0470259809
ISBN 13: 9780470259801
Language: EN, FR, DE, ES & NL

Pharmaceutical Manufacturing Handbook Book Review:

This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear.

Thomas Register

Thomas Register
Author: Anonim
Publsiher: Unknown
Total Pages: 135
Release: 2004
ISBN 10: 1928374650XXX
ISBN 13: STANFORD:36105024685385
Language: EN, FR, DE, ES & NL

Thomas Register Book Review:

Pain Management and the Opioid Epidemic

Pain Management and the Opioid Epidemic
Author: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse
Publsiher: National Academies Press
Total Pages: 482
Release: 2017-09-28
ISBN 10: 0309459575
ISBN 13: 9780309459570
Language: EN, FR, DE, ES & NL

Pain Management and the Opioid Epidemic Book Review:

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Feature Papers

Feature Papers
Author: Michael Henson
Publsiher: MDPI
Total Pages: 402
Release: 2018-10-04
ISBN 10: 3038420700
ISBN 13: 9783038420705
Language: EN, FR, DE, ES & NL

Feature Papers Book Review:

This book is a printed edition of the Special Issue "Feature Papers" that was published in Processes

Continuous Processing in Pharmaceutical Manufacturing

Continuous Processing in Pharmaceutical Manufacturing
Author: Ganapathy Subramanian
Publsiher: John Wiley & Sons
Total Pages: 528
Release: 2015-02-09
ISBN 10: 3527335951
ISBN 13: 9783527335954
Language: EN, FR, DE, ES & NL

Continuous Processing in Pharmaceutical Manufacturing Book Review:

With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.